Thank you for your July 25, 2001 letter to the Occupational Safety and
Health Administration (OSHA) regarding the applicability of the Bloodborne
Pathogens Standard (29 CFR 1910.1030) to the administration of childhood
vaccinations. We appreciated the opportunity to clarify the American Academy of Pediatrics'
(AAPs') concerns over the phone. Since your letter does not ask specific interpretive
questions, a member of your staff requested that we address each of your suggested
"remedies" for their compliance with the standard. Your suggestions are restated below,
followed by OSHA's response. This letter constitutes OSHA's interpretation only of the
requirements discussed and may not be applicable to any scenario not delineated within
your original response.

AAP Scenario: The American Academy of Pediatrics (AAP) is deeply concerned
that the mandated use of safe sharps threatens the success of our nation's childhood
immunization program.

AAP Suggestion 1: Exempt injections for vaccine delivery from mandated
safe sharps to allow comparable studies on sharps injuries and the effectiveness
of sharps with engineered sharps injury protection (SESIPs) to be conducted in
ambulatory healthcare facilities where childhood immunizations are provided.

OSHA Response 1: OSHA does not generally grant exemptions from the
Bloodborne Pathogens Standard. The standard applies to all occupational
exposure to blood or other potentially infectious materials (OPIM) and requires
an employer to determine where those exposures are reasonably anticipated.
The exposure determination must then be documented and appropriate controls
put in place to eliminate or minimize those hazards. The controls implemented include
engineering and work practice controls, personal protective equipment, and employee training.

It would be particularly inappropriate to grant an exemption to the requirement
in 29 CFR 1910.1030(d)(2)(i) to implement engineering controls, which include
SESIPs after the Congress unanimously passed and the President signed the
Needlestick Safety and Prevention Act (P.L. 106-430). The very purpose of
that Act was to make sure that SESIPs are used as part of an overall bloodborne
pathogens program to reduce accidental sharps injuries. Congress found that,
"depending on the type of device used and the procedure involved, 62 to
88 percent of sharps injuries can potentially be prevented by the use of safer medical devices,"
on the basis of CDC findings in March 2000. They also found that the modification of the
Bloodborne Pathogens Standard is appropriate to set forth in greater detail its requirement
that employers identify, evaluate, and make use of effective safer medical devices.

As your letter illustrates and according to the International Health Care Worker
Safety Center at the University of Virginia (EPINet database), needlesticks occurring
from syringes used for intramuscular/subcutaneous injections pose a risk to those
administering the injections. Data collected from several hospitals indicate that needlesticks
occurring from this type of procedure account for the highest number of needlesticks
(17%), along with those from devices used for drawing venous blood samples
(EPINet, 1998). Therefore, when performing IM/subcutaneous injections (e.g., vaccinations,
administration of medication) evaluation and selection of SESIPs are required.

AAP Suggestion 2: Stand by the previous interpretation of the
standard, which permitted employees and front-line employees to conduct their own
risk assessments (based on the facility's history of past injuries and its comparison to
sharps injuries in similar settings using similar sharps devices) and to customize their
decision to switch to SESIPs. Should the work group agree that the existing work
practice controls have proven sufficient to prevent sharps injuries, or that the engineering
controls available would not have prevented the kinds of previous sharps injuries, then
the adoption of the SESIP would be optional.

OSHA Response 2: Implementing engineering and work practice
controls where there is reasonably anticipated occupational exposure to blood or
OPIM has always been a requirement of the standard and has not changed. Soliciting
input from non-managerial employees responsible for patient care regarding the evaluation
of engineering controls (e.g., SESIPs, needleless systems) is a requirement of the revised
standard (January 2001).

Non-managerial employees responsible for direct patient care
must have input in employer decisions about which engineering
controls to adopt, not whether or not to adopt them. The standard does not give the
employer the option to forgo appropriate, commercially available, and effective
engineering controls. If the employer determines, through device evaluation, that no
available devices are appropriate for a specific procedure, that decision must be documented in the Exposure Control Plan (ECP). If the employer feels that a particular
device is cumbersome or awkward, employees may need additional practice or training
until they feel comfortable using a new and different device. Whether or not an engineering
control is chosen for a specific procedure, an annual review of devices is required and that
review must be documented in the ECP.

Again, if appropriate and effective safer options are commercially available for
specific medical procedures where there is reasonably anticipated exposure to
blood or OPIM, they must be used. Appropriateness and effectiveness should
be based on employee feedback, industry feedback, pilot programming, and/or
practical use. Engineering and work practice controls that the employer determines
to be appropriate, after non-managerial employee input, must be documented in the
employer's Exposure Control Plan (ECP). Of course, if using a safer medical device
compromises either patient safety or medical integrity, its use would not be required.

Please keep in mind that the Bloodborne Pathogens Standard and several
other new OSHA standards are written in performance-oriented language,
giving the employer the opportunity to implement the controls which best suit
the safety of his or her employees.

The Centers for Disease Control and Prevention (CDC) and General Accounting
Office (GAO) recommend, and OSHA requires, that the use of safer medical
devices be combined with a comprehensive program including reducing the use
of unnecessary needles, modifying procedures where appropriate, implementing
safe work practices, employee training, promoting safety awareness in the workplace,
and then evaluating the effectiveness of these measures. Where the use of safer
medical devices is not appropriate, it is especially important that the other components
of the program be in place.

Our compliance directive, CPL 2-2.44D
[CPL 2-2.69], Enforcement Procedures for the Occupational
Exposure to Bloodborne Pathogens(soon to be updated), provides several internet
links to websites that have information and tips on evaluating engineering controls. We
encourage you to look at them as aids for your evaluation.

(Correction 3/15/02)

The purpose of the Occupational Safety and Health (OSH) Act is to prevent
the first injury or illness from occurring. No proof of specific prior instances
of exposure is required to trigger OSH Act obligations [Mineral Industries, Etc. v. OSHRC,
639 F.2d 1289, 1294 (5th Cir. 1981)]. Thus, a facility's
past sharps injury rates does not affect compliance with the standard.
As mentioned previously, sharps injuries during the administration of vaccinations
do occur. It is our mission to prevent these injuries.

AAP Suggestion 3: Delaying application of safe sharps for
immunization procedures to allow "payors" time to reallocate funding resources
and providers time to renegotiate contracts with medical supply vendors and
"payors." This would help vaccine providers to secure adequate reimbursement
for additional vaccine administration costs associated with switching to SESIPs.
This delay would also help small medical groups by allowing them to purchase
SESIPs after hospitals and other high volume purchasers may have caused the
prices of such devices to decline.

OSHA Response 3: The requirement to use engineering and work
practice controls (29 CFR 1910.1030(d)(2)) has been part of the standard since it
was originally promulgated in December 1991 and has already been actively enforced
since November 1999.

We will not further delay enforcement of any section of the standard. The revised
standard was published in January 2001, became effective April 2001, and enforcement
of the new provisions (i.e., the solicitation of input from non-managerial employees and
maintaining a sharps injury log) began in July 2001 (October 2001 in OSHA state-plan states).
OSHA inspections to determine compliance with this standard are performed mostly on the basis
of employee complaints. During an OSHA inspection, if an OSHA compliance safety and health
officer determines that an employer has not evaluated and implemented appropriate engineering
and work practice controls, a citation would likely be issued.

With regard to the cost of purchasing safer medical devices, you may find that the
cost is less prohibitive than anticipated. According to the November 17 GAO Report,
Occupational Safety: Selected Cost and Benefit Implications of Needlestick
Prevention Devices for Hospitals, to which you also refer in your letter,
"the greatest dollars savings resulting from a needlestick
reduction program would be the reduced cost of treating healthcare workers
who have sustained needlesticks... these costs include medical treatment costs
for healthcare workers who become infected after sustaining a needlestick;
wages and time lost by these workers; emotional distress suffered by injured
workers, their colleagues, and family members; reduced quality of life and
while rare, lives lost." Some cost estimates for individual needlesticks range
from $200 to $3,000 per injury according to both GAO and the International Health
Care Worker Safety Center (University of Virginia). Most people find that the
benefits of preventing an exposure incident far outweigh the costs of safer devices.

Additionally, if an employee had an exposure incident with a contaminated sharp,
post-exposure follow-up is required. Through evaluation of the incident, an
occupational health practitioner may determine that prophylaxis is not appropriate; however,
follow-up still needs to be provided and paid for by the employer regardless of the type of
device or the associated risk of transmission.

AAP Suggestion 4: Explore ways to make
SESIP purchased in high volume at government discounts
available to pediatricians through programs such as the "Vaccine
for Children Program," State Medicaid program, and bulk purchase
programs from private sources.

OSHA Response 4: While this may be a good suggestion
for minimizing cost, we are not able to comment; this issue is outside of OSHA's jurisdiction.

AAP Suggestion 5: Phase in the implementation
of the Needlestick Safety and Prevention Act (NPSA) requirements.
First, target healthcare workers in high-risk setting who use sharps in
high-risk procedures. Second, target procedures more likely involved in
exposure to blood or OPIM. Third, include sharps used in vaccine injections.

Response 5: With regard to phasing in the enforcement of the
new provisions of the standard (i.e., solicitation of input from non-managerial employees
and maintaining a sharps injury log), this was already done in the period between January
and July 2001 (October 2001 for OSHA state-plan states). OSHA is not targeting any
industry or facility with regard to compliance with the Bloodborne Pathogens Standard.
As mentioned previously, most OSHA inspections are complaint-driven. If an OSHA office
were to receive a complaint regarding exposure to blood or OPIM, an inspection might result,
regardless of the size or function of the facility.

Again, every process or procedure that may result in occupational exposure to blood
or OPIM must be addressed and appropriate controls implemented. Though this has been
a requirement since 1991, we recognize that evaluation and implementation of appropriate
engineering controls can be a time-intensive task. That is why an employer is required to
document his or her actions in the ECP, so that if an OSHA inspection did occur, the
written plan can be consulted.

Thank you for your interest in occupational safety and health. We hope you
find this information helpful. OSHA requirements are set by statute, standards
and regulations. Our interpretation letters explain these requirements and how they
apply to particular circumstances, but they cannot create additional employer obligations.
This letter constitutes OSHA's interpretation of the requirements discussed. Note that our
enforcement guidance may be affected by changes to OSHA rules. Also, from time to time
we update our guidance in response to new information. To keep apprised of such
developments, you can consult OSHA's website at http://www.osha.gov.
If you have any further questions, please
feel free to contact the Office of Health Compliance Assistance
at (202) 693-2190.

Sincerely,

Richard E. Fairfax, Director
Directorate of Compliance Programs

cc: National Institute for Occupational Safety and Health, Cincinnati, OH
Centers for Disease Control and Prevention, Atlanta, GA

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